300 fresh pharma unit applications up for approval in Gujarat: FDCA

Gujarat, one of the major pharma manufacturing hubs in the country, is set for more action as roughly 300 new applications are up for approval with the state food and drugs control administration (FDCA).

Amid an already established ecosystem of API units in southern parts of the state, most of the new applications are for formulations (medicines), said H G Koshia, Commissioner, Food and Drug Control Administration (FDCA), Gujarat.

"FDCA's plant approval committee has received around 300 fresh applications for pharma units in the recent times and roughly 4-5 new applicants approach the committee for approvals of their plant design every week," Koshia said on the sidelines of an industry event here on Tuesday.

On the back of the fresh investments in drug manufacturing facilities, the state government anticipates Gujarat's share in India's pharmaceutical production to go up from current 33 per cent to nearly 40 per cent in the next couple of years. "It takes around two years for the execution of a facility. With such a large number of companies showing interest, we can say that Gujarat will regain its lost glory by once again capturing 40 per cent share in the pharma manufacturing sector in the next couple of years," he added.

Koshia said that the expansion of pharma sector in Gujarat was also supported by one of the lowest drug failure rates in the country at 1.69 per cent, below the national average of 4.5 per cent. Gujarat has the highest number of World Health Organisation (WHO)-compliant pharma units at 642, said Koshia, adding that there were 124 units approved by the USFDA. "Most of these units are in formulations where Gujarat holds a lead," he said.

According to the state FDCA commissioner, the state has benefited from the introduction of Goods and Services Tax (GST), introduced in July 2017, which attracted more investment in the already established ecosystem of pharma industry in Gujarat.

A decade ago, Gujarat used to enjoy over 45 per cent share in drug manufacturing in India. However, with some states offering tax holidays to attract investments in pharma, it led to migration of some units from Gujarat which still had taxes then.

"However, the tables have turned now as the 10 year tax holiday offered by these states is nearing its end. Moreover, GST has provided a level playing field with tax rates becoming common across every state," said Koshia.

Apart from the manufacture of pharmaceuticals, Gujarat also ranks among the states manufacturing machinery for the pharma sector. "Forty per cent of India's pharma machinery comes from Gujarat," Koshia added.